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BS EN ISO 17664-2:2023

Current

Current

The latest, up-to-date edition.

Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices Non-critical medical devices

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

31-07-2024

€285.14
Excluding VAT

Committee
CH/198
DocumentType
Standard
Pages
38
PublisherName
British Standards Institution
Status
Current

This document specifies requirements for the information to be provided by the medical device manufacturer for the processing of non-critical medical devices not intended to be sterilized (i.e. a medical device that is intended to come into contact with intact skin only or a medical device not intended for direct patient contact). This includes information for processing prior to use or reuse of the medical device. Processing instructions are not defined in this document. Rather, this document specifies requirements to assist manufacturers of medical devices in providing detailed processing instructions that consist of the following activities, where applicable: a) preparation before processing; b) cleaning; c) disinfection; d) drying; e) inspection and maintenance; f) packaging; g) storage; h) transportation.

Standards Relationship
EN ISO 17664-2:2023 Identical
ISO 17664-2:2021 Identical

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